Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

MICROPRUNG : Intestinal Microbiota Analysis in Patients With or Without Hirschsprung's Associated EnteroColitis (MICROPRUNG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02857205
Recruitment Status : Completed
First Posted : August 5, 2016
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:

Hirschsprung disease is a congenital abnormality due to the lack of migration of neural crest cells in myenteric and submucosal plexi of the bowel wall. The consequence is the absence of parasympathetic control of the distal bowel from the anal sphincter to various levels. The most common type of Hirschsprung disease alters the rectosigmoid (80%). The incidence is around 1/5000 live births. This anomaly requires a surgical ablation of the aganglionic segment.

Regardless of the surgical complications, patients with Hirschsprung disease are exposed to the risk of Hirschsprung Associated EnteroColitis (HAEC). This variable risk, 4-54%, is responsible to a major part of Hirschsprung disease morbimortality. Its onset is more frequent during the first two years of life and then decrease with age.

Its pathogenesis remains unclear but could be due to intestinal homeostasis breakdown that involves microbiota, intestinal barrier, immune system and enteric nervous system. This breakdown of the mutual benefit relation due to microbiota or bowel anomaly is known to be responsible of Crohn's disease onset. Some studies emphasize the role of microbiota in the pathogenesis of HAEC, but the techniques or the methodology with small numbers of patients limit any conclusion or clinical use.

The study hypothesizes microbiota is a major factor in HAEC onset and in their functional bowel problems. Considering HAEC is more frequent the first two years, it's thought that intestinal microbiota changes with time in those patients. This project is innovative because it will use high throughput sequencing methods and analysis for microbiome analysis on fecal samples from a multicenter cohort of patients at various ages.

Multicentre transversal study.

This study has the potential to significantly modify clinical practice for Hirschsprung disease patients: a better care for HAEC and functional troubles thanks to a better understanding of their microbiota, targetted antibiotic treatment for HAEC, prophylactic treatment of patients at high risk of HAEC.


Condition or disease Intervention/treatment Phase
Hirschsprung Disease Other: Fecal samples Not Applicable

Detailed Description:

Primary objective :

Characterize intestinal microbiota in patients with or without HAEC.

Secondary objectives :

  • Look for a difference in microbiota composition between patients with or without HAEC ;
  • Study the evolution with age of the microbiota in Hirschsprung disease patients ;
  • Study predominant taxonomic classification elements in both groups.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: MICROPRUNG : Intestinal Microbiota Analysis in Patients With or Without Hirschsprung's Associated EnteroColitis
Study Start Date : June 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : September 2018


Arm Intervention/treatment
Fecal samples
High throughput sequencing methods and analysis for microbiome analysis on fecal samples from a multicenter cohort of patients at various ages.
Other: Fecal samples
High throughput sequencing methods and analysis for microbiome analysis on fecal samples from a multicenter cohort of patients at various ages.




Primary Outcome Measures :
  1. Intestinal microbiota composition [ Time Frame: Sampling day ]
    Characterize intestinal microbiota in patients with or without HAEC



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients from 0 to 16 years ;
  • With rectosigmoid Hirschsprung's disease confirmed by rectal biopsies and at surgery;
  • Already operated on, whatever the surgical technique was ;
  • With a health care insurance;
  • Clear information and signed consent form

Exclusion Criteria:

  • Long segment Hirschsprung disease ;
  • Syndromic Hirschsprung disease ;
  • Down syndrome.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02857205


Locations
Layout table for location information
France
Angers University Hospital
Angers, France, 49000
Brest University Hospital
Brest, France, 29000
Caen Univeristy Hospital
Caen, France, 14000
Nantes University Hospital
Nantes, France, 44000
Poitiers University Hospital
Poitiers, France, 86000
Rennes University Hospital
Rennes, France, 35000
Tours University Hospital
Tours, France, 37000
Sponsors and Collaborators
Rennes University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Alexis ARNAUD, MD Rennes University Hospital

Layout table for additonal information
Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02857205    
Other Study ID Numbers: 35RC15_9873_MICROPRUNG
2015-A01317-42 ( Other Identifier: ANSM )
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Case Report Form
Keywords provided by Rennes University Hospital:
Hirschsprung Associated EnteroColitis (HAEC)
Additional relevant MeSH terms:
Layout table for MeSH terms
Enterocolitis
Hirschsprung Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Digestive System Abnormalities
Megacolon
Colonic Diseases
Congenital Abnormalities